Intelligence and Neurodevelopmental Outcome After Prenatal Exposure to Labour Epidural Analgesia: a Sibling Matched Clinical Ambidirectional Cohort Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-16
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

In Belgium, labour epidural analgesia (LEA) has been used for decades in the vast majority of vaginal deliveries (up to 83% of deliveries). Labour epidural analgesia is the most effective and safest way to allow pregnant women a nearly pain-free labour- and birth experience. Recent data showed that the use of LEA was associated with a reduced risk for severe maternal morbidity, neonatal resuscitation and with a reduced risk for low Apgar scores. However, prenatal exposure to labour epidural analgesia has been associated by several study groups with an increased risk for autism spectrum disorder (ASD) in the children, but these studies suffer from several important limitations which may have induced significant bias (e.g., not correcting for unmeasured confounders). Associations with other neurodevelopmental disorders (e.g., Attention Deficit Hyperactivity Disorder (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD)) and cognitive functioning have not been investigated yet. There is hence an urgent need for a study allowing definitive conclusions by overcoming the limitations of the previous studies. The investigators will perform the first sibling-matched clinical cohort study using a prospective investigator-assessment of multiple domains of cognitive functions. The investigators hypothesize that prenatal exposure to LEA will neither be associated with reduced intelligence nor with more neurodevelopmental disorders. Validating this hypothesis holds the potential to grant women the assurance to confidently receive the most efficacious method for labour analgesia, free from apprehension that it might have adverse implications for their children's neurodevelopment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Exposed children: Children prenatally exposed to labour epidural analgesia

Unexposed children: Sibling of an exposed child, Prenatally not exposed to labour epidural analgesia

Exposed & unexposed children: Children born from 1st January 2014 until 1st November 2019, Parental informed consent

Disqualifiers

Children whose mothers underwent maternal surgery or foetal surgery/interventions during the same pregnancy.

Children exposed to general anaesthesia after birth

Children prenatally exposed to chemotherapy, radiotherapy, radiology, oncologic pathology

Children born at a gestational age < 37 weeks or > 42 weeks, or with a birth weight < 2.5 kg

Trial population

Sibling pairs discordant for prenatal exposure to labour epidural analgesia will be included

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Labour epidural analgesia

    Procedure/Surgery

    Prenatal exposure to labour epidural analgesia during delivery

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Exposed1 intervention
Group B: Unexposed0 interventions

Trial outcomes

Primary outcomes

1

Wechsler full-scale intelligence quotient

Will be assessed using the Wechsler Intelligence Scale for Children (WISC). Minimum value: 40, maximum value: 160. Higher scores mean a better outcome.

Time frame
At te moment of neuropsychological testing

Secondary outcomes

1

Indices of the Wechsler intelligence scale

Verbal comprehension, working memory, visual spatial, fluid reasoning, processing speed. Minimum value: 40, maximum value: 160. Higher scores mean a better outcome.

Time frame
At te moment of neuropsychological testing
2

Clinically relevantly decreased intelligence quotient

The absolute risk reduction for a clinically relevantly decreased intelligence quotient, defined as an IQ\<85, will be calculated.

Time frame
At te moment of neuropsychological testing
3

Social responsiveness scale (SRS)

Parental reported social deficits in the autism spectrum. Minimum value: 0, maximum value: 195. Higher scores represent a worse outcome.

Time frame
At te moment of neuropsychological testing
4

Disruptive Behavior Disorders Rating Scale (DBDRS)

Parental reported traits of inattention, hyperactivity and impulsivity (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD). Minimum value: 0, maximum value: 135. Higher scores mean a worse outcome.

Time frame
At te moment of neuropsychological testing

Other outcomes

Sponsors and contacts

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